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QUALITY CONTROL, INSPECTION AND TESTING

2.2 Quality System with Quality Assurance Guidelines

2.2.1 Quality Control System

2.2.1.1 Operation of the System

The Project Manager is responsible for the administration, monitoring and


development of the system and ensures the compliance of the ADVCON to the
specific requirements of construction of academic buildings for JIC as stipulated
in the contract scope of works. The Quality Assurance Manager will directly
report to the ADVCON Management for the activities he is performing.

 The Technical Department under the close supervision of the Project


Manager produces the Quality Control Plan which comprises of specific
work procedures, work instructions and Quality Inspection and Test Plans
(QITP) to become the ADVCON – Quality control working documents.

 The particular conditions of the contract identify the involvement of the


OWNER Representative in the inspection regime for the works and for the
layout of the Quality Inspection & Test Plan (QITP). ADVCON QA
Manager and Officers together with the Engineer will conduct inspection
system to ensure that ADVCON is complying with the agreed
requirements.

 The Engineer will be entitled, during the manufacture, fabrication or


preparation to inspect and test the materials and Plants to be supplied
under the Contract. If materials or Plant are being manufactured,
fabricated or prepared in workshops or places other than those of the
Contractor, the Contractor shall obtain permission for the Engineer to
carry out such inspection and testing in those workshops or places. Such
inspection or testing shall not release the Contractor from any obligation
under the Contract.

If, as per the agreed inspection and testing system the Engineer found some
defects on any work/s that was being undertaken or material/s that was delivered
on site and the Plant were not as per the Contract or specifications (General &
Special), the Engineer has the authority to reject / hold any of this defective works
or materials that were out of the said specifications.

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The Engineer shall inform the ADVCON in writing of these defaults in the
earliest time possible, so that the ADVCON can rectify it without affecting the
progress of

the works. In any case, the ADVCON will bear all expenditures incurred by these
rectifications.

Implementation of activities are defined and documented by the ADVCON


Project Management established quality plans, work procedures and instructions,
method statements and standard details.

This system will be continuously monitored by the Quality Engineers to form the
basis for continued development and improvement of the ADVCON quality
management capability.

The inter-relationship among various departments is depicted in the


Organizational Chart.

2.2.1.2 Allocation of Qualified staff to verify the system

 The ADVCON Project Management provides adequate resources and


assigns suitably trained and experienced personnel to carry out the
verification procedures detailed in this Quality Control system, its quality
of work procedures, standard work instructions / method statements and
Project Quality Inspection & Test Plans (QITP).

 The Project Manager shall plan and delegate operational Quality


Assurance Responsibilities to suitably trained and experienced staff, who
shall carry out verification routines under his guidance and control in
accordance with the Project Quality Plan. All of these responsibilities for
ensuring that ADVCON services fully satisfy the OWNER expectations
and satisfying the OWNER quality requirements.

2.2.2 General View of the Quality Control System

The Quality Control System adopted by ADVCON Project Management is based


on ISO 9002; 1994(E) model for quality assurances as specified in the condition of
contract, technical specifications and other related documents and will form as
the working documents of ADVCON Project Management Quality Control
Program.

2.2.2.1 Site Operation Control

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To identify and plan the production process in which directly affect quality and
to ensure that these processes are carried out under controlled conditions, i.e. use
of established procedures defining the manner of productions, use of suitable
equipment’s and instruments in compliance with the standards and quality
plans, monitoring and approval of the process by the Project Management
Consultant, the OWNER representative.

2.2.2.2 Procurement

Relates to the documented procedures established to ensure that


purchased products conforms to specified requirements of the contracted
scope of works, to relevant technical specifications, drawings and other
standard codes.

2.2.2.3 Materials Identification and Traceability

Where appropriate, it relates to the established procedures for identifying


the products by suitable method from receipt and during all stages of
production delivery and installations.

2.2.2.4 Document and Data Control

The documented procedures, QAC-XXXX, QAC-XXXX to control all documents


and data that relates to the requirements of project technical specification,
contract documents and relevant internationally accepted standard codes

2.2.2.5 Review of Engineering and Technical Submittal

Details the review carried out to ensure that all technical requirements are clearly
defined and documented; capability is assessed and assured to meet the specified
contract or other requirements.

2.2.2.6 Inspection and Testing

The inspection and test procedure detail the provisions to be made for inspecting
supplies and work activities to verify the compliance with the project
specifications.

2.2.2.7 Calibration of Measuring & Testing Equipment’s & Instruments

The calibration procedure establishes the routine checking that are carried out on
measuring equipment/instruments to established that it is performing within the
acceptable limits define in the manufacturer’s original specifications.

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2.2.2.8 Inspection and Test Status

The process for inspection and test status has been incorporated into the control
of non-conformance and procedure of receipt, storage and handling of incoming
materials.

2.2.2.9 Control of Non-Conformance (Products Related)

The procedure describes the system for identifying, segregating and proposing
remedial action to be taken on non-conforming products found in the
Engineering, Procurement and Construction process carried to ensure that
defective work is not built into the service provided and thereby reducing the
compounding cost of repair (immediate action).

2.2.2.10 Corrective and Preventive Action (Process Related)

The procedure is used as the process for continuously improving the quality
system and ensures that effective action is taken to prevent problems. To detect
and eliminate potential causes of problems and where the problems occur. To
ensure that effective corrective action is taken.

2.2.2.11 Receipt, Storage and Handling Of Materials

The procedure establishes authorization levels required to receive materials. The


procedure also identifies the controls required for storing various types of
materials to prevent deterioration and the method of handling required avoiding
damages.

2.2.2.12 Quality Records

The quality records QAC-XXXX, procedure sets out the process for identifying,
preparing and maintaining quality records relating to the processes carried out
by ADVCON Project Management of quality and verify the effective operation of
the quality control system.

2.2.3 Site Operation Control

It is the policy of ADVCON to formally plan those activities which directly affect
quality.

Formal approved written procedures/method statements shall be utilized to


ensure compliance with contractual requirements.

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The standard of our workmanship shall be closely monitored by Supervisors and


Quality Inspectors.

Non-Destructive Testing shall be employed as required to demonstrate


compliance to the OWNER requirements, conditions of contract, engineering
standards and all applicable codes.

Personnel having control of special processes shall be trained to the standard


necessary to perform their duties.

Our equipment/instrument is maintained in line with the manufacturers


recommended requirements and all legislative requirements to ensure the quality
of works.

Procedures which describe the activities and responsibilities with regard to Site
Operation Control are located in the Quality Work Procedures File found in
separate binder. This file shall be issued under controlled conditions.

2.2.4 Procurement

Materials required for the project are procured based on the material submittals
made by the Technical Department as per PROC-XXXX. Orders for the various
materials and services are made on the approved vendor by the Procurement
Section.

2.2.4.1 Requirements for Vendors / Suppliers

The vendor / supplier is required to submit to ADVCON a catalogue or


brochures showing the capability of their product for the assessment of the
Quality Control Manager and the approval of the Engineer. Any material,
instruments or equipment will be scrutinizing by the Quality Control Manager
for their capability as per the required quality or working performance, then to
be submitted to the Engineer for approval prior for the purchase of any material,
instruments or equipment’s necessary for the project. This materials, instruments
or equipment must be as per the required specifications as required from the
contract and it must pass the standards required by the OWNER through its
representative the Engineer. All necessary documents i.e. testing and calibration
certificates must be available together with the products.

2.2.4.2 Purchasing Data

The specific requirements of the materials procured are given in the BOQ of the
contract. These requirements are verified by the user departments and

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procurement is initiated. These specifications are also approved by the OWNER’s


representative for every procurement action.

Purchasing documents are reviewed and approved for the adequacy of specified
requirements prior to release by Technical Department for their relevant material
as per PROC-XXXX. Where verification of purchased products at our storage is
proposed, verification arrangements and the method of product release are
specified in the purchasing documents PROC-XXXX.

2.2.5 Materials Identification and Traceability

The ADVCON is not a manufacturer. The ADVANCE COMPANY procures all


their equipment and materials from the vendors and suppliers.

Since the ADVCON has no requirements for identification of materials, they will
just accept the Supplier’s system of identification of his materials, items or goods.

Documented procedures are established and maintained for identifying the


product by suitable means from receipt through installation, testing and final
hand-over.

The following quality Procedures explains our methods, requirements and


responsibilities.

PROC – XXXX -Materials Identification and Traceability

QAC-XXXX -Inspection and Test Status

(If any data appear enigmatical, it will be defined after award of contract)

2.2.6 Document and Data Control

Documented procedure QAC-XXXX, QAC-XXXX controls the documents and


data relate to the requirements of ISO 9002/1994(E). The documents include
OWNER’s drawings, Standards and Technical Specifications, Procedures,
Method Statement, Quality Inspection Test Plan.

2.2.6.1 Document and Data Approval and Issue

A master list identifying the current status of documents is readily available with
ADVCON Project Management Staff to preclude the use of invalid and/or
obsolete documents. These documents are guided as per the procedure and
ensure that:

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a) The documents and data are reviewed for adequacy and approved
before issue.

b) The pertinent issues of appropriate documents are available at all


locations where operations essential to the effective functioning of
the quality system are performed.

c) Invalid and/or obsolete documents are promptly removed from all


points of issue or use, or otherwise protected against unintended
use.

d) Any obsolete documents retained for legal and/or knowledge


preservation purposes are suitably identified.

e) Documents for all work testing that was been conducted by the
Laboratories will be kept and filed in a manner that the OWNER
and concerned authorities be accessible at all times for retrieval and
for review.

The procedure QAC-XXXX and QAC-XXXX ensures technical data and


documents from/to OWNER/external agencies are properly identified and
distributed to the concerned.

2.2.6.2 Document and Data Changes

Changes to documents and data are reviewed and approved by the same
functions that prepared and issued the initial documents, the concerned to have
access to pertinent background information upon which to base their review and
approval. The amendment history is available with the function that prepared
the original documents.

2.2.7 Design Control

The OWNER’s design and contract drawings will receive by ADVCON Technical
Department as per Procedure QAC-XXXX. The Technical Manager reviews these
drawings for its completeness (QAC-XXX) and if necessary, seeks clarification as
per QAC-XXXX Request for information. Then the design depicted in the contract
drawings and specifications are transferred into detailed construction shop
drawings required for execution.

Updated shop drawings are submitted to the OWNER for approval. As the
design and construction evolves, necessary revisions are made in the shop
drawings as per the procedure.

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Temporary work drawings & shop drawings for all works will be done
progressively as per the natural ground cross sections being surveyed by the
ADVCON surveyors and upon the acceptance of the Consultant’s surveyor and
upon approval of the Engineer and according to the drawing of the project.

As the design and construction evolves, revisions are being made for the work
drawings and shop drawings as per the requirements of the Engineer. This
drawing will be reviewed by the Engineer’s Technical staff and upon reviewing
and found out it needs corrections or revisions, The ADVCON technical people
will rectify the subject as per the corrections made by the people concerned and
to be re-submitted to the Engineer for final approval. No work is to be done
without the approved work drawings and shop drawings by the Engineer.

As-built drawings will be prepared upon completion in part or in whole of the


Project, which to be submitted to the OWNER through its representative, the
Engineer of the project, for approval.

2.2.8 Inspection and Test Plan

All inspection and testing, QAC-XXX, shall be carried out in accordance with the
ADVCON Project Management’s standard documented procedures.

All work inspection and testing is to be carried out in accordance with OWNER
Specifications.

See attached Appendix B for the abovementioned testing specifications as


required for the completion of the said project in a proper way.

The Engineer and its supervision staff will witness and supervised the testing to
be done for the required

2.2.8.1 Receiving Inspection

Receiving and testing requirements are listed in the Project Quality Control
Inspection and Test Plan/s (QITPs).

All materials and equipment shall be inspected and verified as conforming to


contractual requirements on receipt. The level and extent of the inspection shall
be governed by the type of material/equipment.

When materials or components are released for urgent use before the receiving
inspection is completed it shall be positively identified and recorded as not
inspected. Such items shall be inspected before installation or use.

2.2.8.2 In-Process Inspection and Test

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All inspection and testing shall be undertaken by ADVCON in a controlled


manner. Use shall be made of documented procedures and approved quality
control inspection and test plans.

2.2.8.3 Final Inspection and Test

All materials shall undergo final inspection and test to ensure that they comply
and function with the design criteria and the actual operating conditions. All
quality related documentation shall be reviewed and verified as being correct
and, if required shall be made available to the OWNER.

2.2.8.4 Inspection and Test Records

Quality records, QAC-XXXX, pertaining to completed items shall be maintained.


These records shall show the results of all agreed inspections.

The following Quality Procedures illustrate the requirements and responsibilities


associated with this activity.

PROC-XXXX -Materials Control

QAC-XXXX -Inspection and Test Status

(If any data appear enigmatical, it will be defined after award of contract)

2.2.9 Calibration of measuring Inspection and Test Equipment

The ADVCON employs an independent Specialist Testing Laboratory for its


resource to ensure that the required quality standards of all inspection and test
equipment are met. The ADVCON ensures that the specialized equipment used
by the Independent Laboratory for testing shall be maintained to the required
standards of calibration and contractual requirements.

Calibration and Maintenance documentations will be kept by ADVCON as


reference for the assurance that the Test Equipment’s were being maintained and
calibrated in continuous sequence to ensure the good performance of these
equipment’s.

Survey instruments will be maintained and calibrated by the supplier/s or any of


its approved maintenance establishment to ensure the good performance of these
measuring instruments once a year or whenever these instruments need
maintenance or calibration. If unforeseen incident happens and the survey
instruments was damaged, the ADVCON will at once send the instrument to the

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qualified technician for repair/s, as this may affect the progress of the survey
works.

The ADVCON ’s approved sub-contracted testing laboratories, which carry out


the calibration of instruments, shall have test equipment traceable to the
applicable International Standards and provide Certified Records of Calibration
where necessary.

2.2.10 Inspection and Test Status

Items purchased from a supplier shall be either inspected at the Supplier’s


premises by ADVCON Project Management Staff or subjected to the required
level of inspection on receipt. The Supplier has the responsibility to comply with
ADVCON ’s requirements for inspection and testing of all material, components
and items manufactured or produced by him according to the agreed contractual
requirements.

No items shall be dispatched from any facility without the prior written authority
of the ADVCON Project Management.

The ADVCON Project Management fabricates or installed system shall be


inspected and tested as required by the documented Quality Control Inspection
and Test Plan (QITP) or other approved procedures.

The ADVCON Quality Procedure QAC-XXXX Inspection and Test Status


describe the methods of maintaining the inspection status of all products.

2.2.11 Control of Non-Conformance

The ADVCON Project Management (Technical Department) shall control all


known Non-Conformances QAC-XXX. Non-Conformances can be described as
items, materials or services which do not meet the approved specification or
requirements.

All known Non-Conformances shall be reported to The ADVCON Management


(Technical Department) for review and disposition. Non-conformances reported
shall be reviewed by The ADVCON Technical Department and agreements shall
be reached with regard to their disposition according to the findings made after
each review.

Non-Conformances shall NOT be left outstanding and should be resolved as


soon as practically possible. Records shall be kept of all Non-Conformances by
the Technical Department and these records shall form part of the final document
package.

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All Vendors and Suppliers shall report all Non-Conformances to ADVCON


Project Management. All Vendors and Suppliers shall submit their Non-
Conformance procedure to ADVCON Project Management for review and
approval.

All Non-conformance procedures from all parties, vendors and suppliers

Shall comply with the ADVCON procedure and shall as a minimum detail the
following;

a) How Non-Conformances are reported?

b) Who is responsible for addressing and evaluating them?

c) What method of control exists to respond to them?

d) The steps taken to ensure that they do not re-occur.

The decision on the acceptance of Non-Conformance resolution is normally at the


discretion of ADVCON Project Management or by the OWNER as deemed
required.

The following are normal resolutions taken by ADVCON (or OWNER) after
reviews of Non-conformances of materials, items and /or goods supplied.

 Acceptance as is (may require a formal concession).

 Reworking of the items to achieve an acceptable standard.

 Rejecting or scraping of the items.

Any re-work to items, etc. shall be fully recorded. Re-inspection should always
be performed.

Where corrective action is required the Vendor/Supplier shall propose such


action and ADVCON Project Management shall give written approval prior to
any re-work. All corrective actions shall be recorded.

Systems shall be available to identify, document, segregate (when practical) and


assess the disposition of non-conforming products or services. Individuals and
departments affected by non-conforming items shall be advised as soon as
practically possible.

The following Quality Procedures are applicable to all parts of the work.

PROC-XXX -Materials Control

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QAC-XXX -Inspection and Test Status

QAC-XXX -Control of Non- Conforming Products

The register of all Non-Conformances shall be reviewed by The ADVCON


Project Management on a monthly basis.

(If any data appear enigmatical, it will be defined after award of contract)

2.2.12 Corrective and Preventive Action Procedure

Corrective and Preventive Action, QAC-XXXX, will be done by The ADVCON


Project Management on an as going, as required basis in an effort to constantly
improve the Management’s system with its internal and external operations.
Corrective and Preventive Action forms part of ADVCON Project Management’s
Quality System activities in all facets of its operations and endeavors.

Internal procedures are in place to ensure that all The ADVCON Project
Management Staff and personnel are aware of the actions which are necessary if
and when situations arise which require corrective action.

These procedures also ensure that Preventive Action is taken by the Management
to alleviate such situations from re-occurring.

OWNER’s site instructions or issued Non-conformance item lists (if any) will be
analyzed by the ADVCON Project Management appropriate personnel to ensure
that an understanding of such situations is reached and that assurances can be
given to the OWNER on all as-going works.

All such actions that arise throughout the year are recorded. These, then form
part of management’s annual review cycle. If a decision is reached that further
action is required at a later date then this will be carried out.

Effective corrective actions require the following:

 A reliable reporting system.

 The analysis of the reports.

 To conduct an in-depth investigation to locate the root causes.

 To ensure the required level of control I applied to prevent the recurrence


of the original non-conformance.

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Quality Procedures QAC-XXXX Corrective and Preventive Action and QAC-


XXXX Investigation report describe how ADVCON Project Management
implements and controls these activities.

2.2.13 Receipt, Storage and Hauling of Incoming Materials

2.2.13.1 Handling

Procedures are in place for the handling of all materials and equipment.
The ADVCON Project Management provides suitable handling and
rigging equipment to allow the safe manipulation of all materials and
items. This assists in preventing damage and deterioration to all products.
For special items, ADVCON shall seek the advice and instruction from the
supplier regarding handling procedures.

2.2.13.2 Storage

The ADVCON Project Management shall provide suitable storage facilities for
protection, identification and control of all materials and equipment according to
the Supplier recommendation.

2.2.13.3 Packaging

All items shall be stored in accordance with the ADVCON Project Management
standard procedures. Special items shall be packed and marked in accordance
with the Supplier’s instructions. Items shall be packed and marked in accordance
with the OWNER’s requirements.

2.2.13.4 Preservation

Items shall be in accordance with the ADVCON Project Management standard


procedure. Environmentally sensitive products shall be segregated and
monitored to ensure that no deterioration is allowed to happen.
Special items shall be stored to ensure that their preservation is in line with
manufactures instructions.

2.2.13.5 Delivery

The ADVCON Project Management shall employ experienced companies to


transport all products. Clear written instructions shall be given to ensure that
products are properly protected at all times. Inspection shall take place at the
point of dispatch by The ADVCON Project Management Staff, their agents or the
vendor / supplier.

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A receiving inspection shall take place at their final destination point.

Vendors and suppliers employed by The ADVCON Project Management shall


have similar procedures which comply with the Management’s requirements for
handling, storing, packing and delivery.

All P. O’s shall contain explicit and concise instructions to Vendors and Suppliers
with reference with the above both their works for internal control, during
shipping and upon receipt.

2.2.13.6 Procedure

Quality Procedures Materials Control, PROC-XXXX relate to the requirements


and responsibilities of ADVCON Project Management Staff when handling or
storing any material.

2.2.14 Control of Quality Records

Records to be kept for the project shall be agreed with the OWNER. This
information shall form part of the ADVCON Project Management’s Project
Quality Plan which are then transferred to applicable Quality Control Inspection
and Test Plans (QITP’s), ADVCON ’s Vendors and Suppliers.

The following registers/files shall be maintained as a minimum by The ADVCON


Project Management Staff.

Title Register Number Responsibility


Non-Conformance -QAC-XXXX QC Manager
Register
Corrective Action –QAC-XXXX QC Manager
Inspection and Test Plan -QAC-XXXX QC Manager /
Supervisors
Purchase Order Register -PROC-XXXX Procurement
Manager

(If any data appear enigmatical, it will be defined after award of contract)

The ADVCON must maintain all quality records and files and must be stored
correctly and in a manner that these records and files be safe from losses or
damages and at any time shall be readily retrievable.

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All records must legible and identifiable to any specific work location/s. These
records must comply with all existing and contractual requirements from the
OWNER. Records relating to the Quality shall be maintained live for as long as a
project is on-going. Thereafter they shall be removed to an archive file or as
agreed to in contracts with the OWNERs.

2.2.15 Quality Auditing

The Quality Assurance Manager must delegate a competent person for the
purpose of internal auditing of all records for quality aspects of the said project.
He must see to it that all quality activities had been properly done and in
accordance with the required standard and procedure as stated in this Quality
Control Plan and as required from the contract.

He must see to it that all documents and records and all test results are being
properly documented and recorded and be kept in orderly and safe manner so
that it will always be ready for review and retrieval upon request by any
personnel from the ADVANCE COMPANY, the Engineer or the OWNER.

2.2.16 Training

As required, any personnel working with the Quality Control Team must be an
efficient and a competent person to avoid any mistake on their job. In case a
member of the team is not that competent to perform his job, then training must
be implied.

 Any member who is assigned for assessing any kinds of equipment, heavy
or light, must be trained regarding the equipment, its parts and its use, so
that he may know the proper part/s to be used and its quality in case
repair is being done, so that, that equipment will be performed well upon
resuming its work.

 A member assigned for the sampling and testing of the work on site or in
the Laboratory needs to be trained properly regarding the work he is
performing to avoid any mistakes that may affect the quality of the work.

2.2.17 Statistical Techniques

All materials, manufactured articles, and machinery incorporated in the


Permanent Works shall meet all quality requirements of the contract. They must,
in all cases, be approved by the Engineer prior to their inclusion in the Work.

The ADVCON shall, before placing any purchase order for materials,
manufactured articles, and machinery to be a part of the permanent works,

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submit for the approval of the Engineer, a complete description of such items, the
names of the firms from which he proposes to obtain such items, together with
copies of all test records proving compliance with Contract provisions. No such
items shall be ordered from any firm without the approval of the Engineer.

2.2.12.1 Sampling and Testing

All materials shall be presented to the Engineer for inspection, testing and
acceptance before incorporation into the Work. All materials being used
are subject to inspection, testing or rejection at any time prior to
incorporation into the Work.

2.2.12.1.1 Sampling

All sampling must be in accordance with the standard/s stated in the contract.
Materials subject to statistical based acceptance shall be sampled randomly which
provides that all units being produced have an equal chance of being selected for
sampling and testing.

When sampling a material for statistical acceptance, the samples must be selected
using and approved random number selection procedure detailed in the
following paragraph or other random number selection procedure approved by
the Engineer. At least five (5) random samples from a lot of materials are needed
to make an acceptance statistical evaluation.

2.2.12.1.2 Random Sampling

All published sampling tables are prepared on the assumption that samples are
drawn at random; i.e., at any one time each of the remaining uninspected units of
product has an equal chance of being the next unit selected for the sample. To
conduct sampling requires that (1) random numbers are generated and (2)
random numbers be applied to the product at hand.

Random sampling shall be used for selecting when or where to take a sample. In
large lots, the method recommended by the M.O.T. is stratified (proportional)
random sampling because it prevents groupings of samples by using sub lots and
spreading the sample over the entire lot.

2.2.12.2 Quality Control Chart

The quality of materials and construction shall be controlled using control charts
based on statistical techniques. The control charts shall be prepared and kept
current daily by the ADVCON. These charts shall be submitted, if required, to the
Engineer every month for review and approval. The charts shall be drawn in the

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form of graphs with property characteristics on the vertical axis and test numbers
on the horizontal axis.

Target line, upper and lower control and warning limits shall be drawn as
directed by the Engineer. The Engineer will divide the work and the materials
into lots. Each lot will be evaluated separately.

Guidance for Quality Assurance Project Plans

2.2.18 An Overview of Quality Assurance Project Plans

What is a QA Project Plan?

A QA Project Plan describes the activities of an environmental data operations


project involved with the acquisition of environmental information whether
generated from direct measurements activities, collected from other sources, or
compiled from computerized databases and information systems.

What is the purpose of the QA Project Plan?

The QA Project Plan documents the results of a project’s technical planning


process, providing in one place a clear, concise, and complete plan for the
environmental data operation and its quality objectives and identifying key
project personnel.

What is the difference between a Quality Management Plan and a QA Project


Plan?

A Quality Management Plan describes an organization’s quality system, i.e., its


systematic approach to quality assurance, while a QA Project Plan describes the
necessary QA procedures, quality control (QC) activities, and other technical
activities that will be implemented for a specific project or program.

May I combine a Quality Management Plan and a QA Project Plan into one
document?

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Yes. With permission of the QA Manager of the organization sponsoring the


work, these two documents may be combined into a single document for small
programs, grants, and contracts. The combined document should address
satisfactorily all the elements of both documents.

What are the benefits of a QA Project Plan?

The benefits of a QA Project Plan are to communicate, to all parties, the


specifications for implementation of the project design and to ensure that the
quality objectives are achieved for the project. It does not guarantee success every
time, but the prospects are much higher with a QA Project Plan than without one.

Up-front planning eliminates approaches that do not work well (or not at all),
which has the potential to reduce the cost of lost time and rework.
Implementation as prescribed, with appropriate QC practices employed,
increases efficiency and provides for early detection of problems, either in the
field or in the laboratory. This again can save time and money from the rework
and enable the ability to make decisions more expeditiously. For example,
following calibration procedures will help to assure the credibility and usability
of data generated by laboratory instruments.

When should a QA Project Plan be prepared?

A QA Project Plan is prepared either as part of or after the project planning


process. But in all cases, the QA Project Plan should be completed and approved
before the project is started.

How do I develop a QA Project Plan?

The following is a brief summary of the process:

 ADVCON will find out what needs to be done, based on what is known
about the site or situation.

 ADVCON will assemble a project team with the necessary expertise.

 ADVCON WILL plan what can be done, or what will be done to obtain
data of known quality that are good enough to support the decisions to be
made or the study questions to be answered.

 ADVCON will write the QA Project Plan.

 ADVCON will submit the QA Project Plan for peer review, input, and
approval, revising it as needed.

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 ADVCON will distribute the approved QA Project Plan to all pertinent


individuals involved with the project.

 ADVCON will begin work while implementing the plan, but remember to:

o Document any changes in the QA Project Plan,

o Get re-approval before initiating the change, and then

o Distribute the updated version.

2.2.19 ADVCON Policy

You will find ADVCON policies and other tools and guidance on the Quality
Staff’s web site, that we will construct it to serve this part.

Should a QA Project Plan be approved before work begins?

Yes. All work involving the collection or use of environmental data, by or on


behalf of ADVCON, is to be done with an approved QA Project Plan. This policy
applies to work performed by or on behalf of ADVCON. A QA Project Plan
should generally be approved before any environmental data collection
operation starts. Examples of exceptions include:

 Circumstances warrant immediate action to protect human health and/or


the environment, or

 Operations are conducted under police powers.

Advance approval ensures that all of the planning steps, including connecting
actions with needs, are completed. Clear documentation increases the likelihood
that the project will achieve its intended results. If the plan is not approved
before work begins, a stop-work order may be issued.

Where can I get information on the graded approach to QA Project Plan


contents?

The term “graded approach” appears in the Quality Manual where it states that
the level of detail in the quality management plan should be “based on a
common sense, graded approach that establishes QA and QC activities
commensurate with the importance of the work, the available resources, and the
unique needs of the organization.” In referring to the QA Project Plan, the
Quality Manual states that ADVCON organizations may tailor these QA Project
Plan specifications in their own implementation documents to better fit their

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specific needs. Therefore, consult with the project officer or QA Manager


regarding the application of the graded approach to your project.

When should I revise my QA Project Plan?

 When changes affect the scope, implementation, or assessment of the


outcome, the plan is revised to keep project information current.

 The Project Manager, with the assistance of the QA Manager, determines


the impact of any changes on the technical and quality objectives of the
project.

 For long-term projects, such as multi-year monitoring programs, the QA


Project Plan is reviewed annually by the Project Manager to determine the
need for revision.

When should I submit a revised QA Project Plan for review?

When a substantive change is warranted, the originator of the QA Project Plan


revises the plan to document the change, and then submits the revised plan to the
approving authority. Implement the change only after the revision has been
approved. Send the revised plan to all the individuals cited in the distribution
list.

How long is a QA Project Plan kept after the project ends?

Document retention should comply with the approving organization’s


specifications first, and the specifications of the organization performing the
work second.

2.2.20 Content of QA Project Plan

What is generally contained in a QA Project Plan?

The QA Project Plan is divided into four basic element groups: Project
Management; Data Generation and Acquisition; Assessment and Oversight; and
Data Validation and Usability. Each group consists of standard elements, 24 in
all, that pertain to various aspects of the project.

A QA Project Plan that addresses the basic elements will define and
describe the following:

 who will use the data;

 what the project’s goals/objectives/questions or issues are;

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 what decision(s) will be made from the information obtained;

 how, when, and where project information will be acquired or generated;

 what possible problems may arise and what actions can be taken to
mitigate their impact on the project;

 what type, quantity, and quality of data are specified;

 how “good” those data have to be to support the decision to be made; and

 how the data will be analyzed, assessed, and reported.

What if some of the 24 elements do not apply?

QA Project Plans will vary in their level of complexity, based both on the nature
of the work being performed (such as the collection of new data or the use of
previously collected information), available resources, and the intended use of
the data.

Following the principle of the graded approach, if an element is not applicable,


then indicate why it is not relevant.

Can additional information be specified beyond the standard 24 elements?

The organization sponsoring or overseeing the work may specify additional


information to clarify project specific information.

If this information is documented in other places, do I rewrite that information


into this QA Project Plan?

Referring to existing documents can reduce QA Project Plan preparation and


review time and length. Any documents prepared before the QA Project Plan,
such as standard operating procedures (SOPs), sampling and analysis plans
(SAPs), work plans, environmental site assessments, literature files, and data sets
from other projects, may be appended.

How long is a QA Project Plan?

A QA Project Plan should have enough information to describe project objectives


and details. The number of pages needed to address this information will vary
with the complexity of the project and intended use of the information. A plan
for some environmental data operations may involve a qualitative discussion of
the experimental process and its objectives, while a plan that describes a complex

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environmental project may involve extensive documentation to adequately


describe activities.

May I use the same QA Project Plan for standard activities?

Multi-year projects, and projects conducted at multiple sites, having the same
project objectives and sampling and analytical processes, may be described in a
generic QA Project Plan. You may describe site specific activities in supplements,
for example, separate field sampling plans. Review generic plans annually to
determine if any changes are necessary.

2.2.21 QA Project Plans and ADVCON Quality System

How does the QA Project Plan fit into the ADVCON Quality System?

ADVCON Quality System consists of three levels or tiers:

 a policy level,

 a program level,

 and a project level

The Project Level addresses project-specific activities. The tools for this level
include:

 Systematic Planning;

 Quality Assurance Project Plans;

 Standard Operating Procedures;

 Technical Audits;

 Data Verification and Validation; and

 Data Quality Assessment.

What is the role of systematic planning in developing the QA Project Plan?

Systematic planning is a process in which you identify the problem to be


investigated or the decision to be made, and then define the project’s objectives,
the type, quantity and quality of information needed, the technical and quality
control activities, and the level of oversight that will ensure project criteria are
satisfied. ADVCON stresses systematic project planning.

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2.2.22 Developing, Reviewing, and approving QA Project Plan

Who is included in developing the QA Project Plan?

Project planning necessitates the coordinated efforts of many individuals, such as


those who will generate information and those who will use the information or
make decisions based on that information. These individuals include: decision
makers, project managers, regulators, stakeholders, modelers, risk assessors, and
technical staff (for example, hydrologists, chemists, data validates, samplers, and
statisticians). In addition, peer reviewers and individuals with varied expertise
ensure that technical areas are sufficiently addressed, thus helping to minimize
problems during implementation.

Who is responsible for ensuring that the Plan is written?

Those who are both involved in planning the project and experienced in
environmental data operations, prepare and/or assist in the preparation of the
QA Project Plan.

Who reviews the plan?

This varies with each organization. Reviewers with expertise in the project
specific areas, such as program managers (decision makers), QA staff
independent of project management, and project field and laboratory technical
staff, should review the plan.

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What is included in a QA Project Plan review?

Reviewers should:

 Ensure that the information is accurate and complete;

 Ensure that all appropriate elements are addressed;

 Ensure that the plan identifies the project's technical and quality
objectives, and that the intended measurement and data acquisition
methods will satisfy these objectives;

 Confirm that the planned assessment procedures will be adequate to


evaluate the project; and

 Confirm that there is a process to identify any limitations on the use of the
data.

These reviewers may also use tools, such as a checklist, in their review.

Who approves the QA Project Plan?

The approving authority will vary with the individual organization. The
ADVCON organization’s Quality Management Plan establishes how, when, and
by whom development, review, approval, and effective oversight of QA Project
Plans should occur. This includes processes for extramural (non-ADVANCE
COMPANY) organizations that prepare QA Project Plans. For ADVCON
projects, the Project Manager or Project Officer, and the QA Manager usually
approve the QA Project Plan. For extramural projects, the responsible
organization’s Project Manager, or Principal Investigator, and QA Manager may
review and approve the QA Project Plan, and then submit it for OWNER
approval Quality Management Plan). It is also beneficial if other key staff, such as
the laboratory directors and prime contractors and subcontractors, sign the plan
to indicate their review and approval.

What types of approvals exist?

In situations where only non-critical deficiencies in a QA Project Plan have not


been resolved (such as a final organizational chart or a data analysis procedure
that will not be followed for weeks), conditional approval may be given to allow
the project to start while these deficiencies are being resolved. The plan is then
resubmitted for approval when the information is finalized. The concept of

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conditional approval, however, will vary with individual organizations; some


organizations may not permit conditional approval of a QA Project Plan.

2.2.23 Distributing QA Project Plan

Who gets a copy of the QA Project Plan?

All personnel involved in the project should retain or have access to the current
version of the QA Project Plan. This may include the Project Manager, laboratory
manager, field team leader, modeler, QA Manager, data reviewers, and any
essential contractor and subcontractor personnel involved with the project.

2.2.24 Implementing the QA Project Plan

Who is responsible for implementing the QA Project Plan?

The organization performing the work is responsible for ensuring that the QA
Project Plan is implemented as written and approved, whether this work is
conducted by contract personnel or in-house personnel. Ultimately the Project
Manager is responsible for project activities. A clearly written QA Project Plan
will help the Project Manager implement the plan, because all project personnel
will understand the specifications before the start of data generation activities.

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