BTC/262-04 B0: Institution

Document No.
Institution Name ባህርዳርፖሊቴክኒክኮሌጅ BTC/262-04

BAHIRDARPOLYTECHNICCOLLEGE
Title: On-Site Road Construction and Maintenance Management Level IV Issue No. Page No.
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SECTOR: ECONOMMIC INFRASTRUCTURE

SUB-SECTOR: ROAD CONSTRUCTION
TVET PROGRAM TITLE: On-Site Road Construction and
Maintenance Management Level IV
UNIT OF COMPETENCY: Establish Quality Systems and Procedures
MODULE TITLE: Establishing Quality Systems and Procedures
MODULE CODE: CON RSC4 M04 0911

PROGRAM: REGULAR AND EXTENSION
LEARNING GUID #1
COMPLIED BY :- F.M
03/06/ 2014E.C
BAHIRDAR
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LEARNING MODULE Logo of TVET Provider
TVET PROGRAM TITLE: On-Site Road Construction and Maintenance Management Level IV
MODULE TITLE: Establishing Quality Systems and Procedures
MODULE CODE: CON RSC4 M04 0911
NOMINAL DURATION: 80 hrs
MODULE DESCRIPTION:
This module covers the knowledge, attitudes and skills required to monitor quality of work, establish quality
specifications for work outcomes, participate in maintaining and improving quality at work, identify hazards
and critical control points in the maintenance work, assist in planning of quality assurance procedures, report
problems that affect quality and implement quality assurance procedures
LEARNING OUTCOMES:
LO 1 establish quality specifications for work output
LO 2 identify hazards and critical control points
LO 3 assist in planning of quality assurance procedures
LO 4 implement quality assurance procedures
LO 5 monitor quality of work outcome
LO 6 participate in maintaining and improving quality at work
LO 7 report problems that affect quality

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How to Establish Quality Control Processes
The term "quality" has a relative meaning. This is expressed by the ISO definition: "The totality of
features and characteristics of a product or service that bear on its ability to satisfy stated or implied
needs". In simpler words, one can say that a product has good quality when it "complies with the
requirements specified by the client". When projected on analytical work, quality can be defined as
"delivery of reliable information within an agreed span of time under agreed conditions, at agreed costs,
and with necessary aftercare". The "agreed conditions" should include a specification as to the precision
and accuracy of the data which is directly related to "fitness of use" and which may differ for different
applications. Yet, in many cases the reliability of data is not questioned and the request for specifications
omitted. Many laboratories work according to established methods and procedures which are not readily
changed and have inherent default specifications. Moreover, not all future uses of the data and reports can
be foreseen so that specifications about required precision and accuracy cannot even be given.
Consequently, this aspect of quality is usually left to the discretion of the laboratory. However, all too
often the embarrassing situation exists that a laboratory cannot evaluate and account for its quality simply
because the necessary documentation is lacking. Testing/Inspections
Barriers to Success
There are a large number of factors that may influence the effectiveness of a project quality
management program. Some barriers to successful management system implementation at
construction organizations involve the very nature of the construction process. The projects are
unique, locations vary, work volume fluctuates, staff changes, the work is labor intensive, the
workforce tends to be transient, projects are subject to change and delays, the key team members
routinely change, the supply chain is extensive, multiple organizations are involved that have
differing visions, values, processes, and practices, weather can vary, some partners fail to deliver
on their promises, the industry is generally confrontational rather than cooperative in
relationships are driven by general self interest.
In addition, the industry is conservative and slow to embrace change. Most contactors are small
and lack sophistication and resources. Effectively managing quality becomes challenging due to
these and a multitude of other factors.
Contractor Quality Management Process
All contractors make an effort to control quality, but generally most of them do not have a robust
quality management process in place. In many cases, they do not have a written program either.
Traditionally, the project superintendent is responsible for the quality of the work. And the
superintendent depends of the different craft workers to follow normal and customary industry
practice when it comes to the quality of the work. Such a process depends a lot on to the ability,
knowledge, discretion, and diligence of workers, and the supervisor’s persistent and careful
oversight.
Under such a ”loose” management system, there are many factors that come into play which
must be managed well to ensure that the resulting quality of the work will meet expectations.
The workforce must be qualified, so keeping qualified workers on the payroll and managing the
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worker workloads, as well as the hiring practices, come into play. Ensuring that the
has the time to oversee work quality and manage it effectively becomes important. Having
management oversight of the quality process will ensure that standards are met. To some extent,
this is how many of the construction firms try to ensure the achievement of contact quality
requirements.
A more structured approach is to draft a quality management program, devise a quality

management process, train supervision on the process, implement a control system, hold people
specifically accountable, and review performance and results. Continuously improve the process
where possible. Following is a framework for a sample quality management process that may
become the basis for managing quality of the project delivery process at a construction company.
Failure to meet project quality requirement can have a number of negative connotations on the
project delivery process. It creates extra work for the parties involved, but has the greatest impact
on the contractor, though it may negatively influence the designer and the owner to some extent.
It can damage business relationships and possibly lead to time-consuming and costly litigation
for contractors. In a. research study conducted a few years ago, the findings revealed that costs
associates with rework (having to redo a step or portion of construction due to poor
craftsmanship or change in plan) were as high as 12 percent of the total project cost and required
as much as 11 percent of the total project working hours.
Quality Assurance and Quality Control
The construction project quality is managed by a program which has two different elements. One
is the quality control (QC) program and the other is the quality assurance (QA) process. These
two elements have somewhat different functions. Whether you are the project owner, the
designer, or the contractor, each has a stake in the effectiveness of the QA/QC management
process. If the quality of the product comes into question, and rework is required, it can become
a costly proposition and may become an issue for the contractor. Some unacceptable quality
issues can lead to costly litigation and damage reputations and relationships. Therefore,
managing quality is an important aspect of a successful project delivery process.
The quality control element defines how the contractor expects to manage the quality
requirements of the project as defined by the specifications. And the quality assurance element
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define the steps the contactors will take to ensure it. The first thing contractors need
themselves of is that there is a clear understanding of any vague specified quality standard and
that workmanship is linked to specific and measurable standards. If there is no way to clarify
them or there is complexity involved in the work, then a mockup or sample of the work should
be made and approved so that it may be used as a standard to which subsequent work may be
compared. This can also prove cery useful in managing quality with subcontractors.
Elements of a Quality Management Process
Following are the elements involved in the development of a quality management process
Quality Standards
Review of the specifications for any quality requirement is an important first step in
understanding and managing the resulting project quality. Documentation of clarifications of any
of the quality requirements, and understandings arrived at with the designer and/or project owner
becomes part of the quality standards. This sets the basis for the contractor’s quality management
program (CQMP). This information must be provided to the project staff.
Contractor Quality Management Program
The contractor’s quality management program is a written document defining the contractor’s
processes, practices, and procedures, which are to ensure the project’s quality requirement are
met or exceeded. The program has two elements which are the quality control plan and the
quality assurance procedures.
QC Plan: Quality control (QC) is the contractor’s definition of how the project quality will be
managed during construction of the project. Any unique project quality requirement must be
defined in a project specific document. It defines who is responsible for achieving the quality
standards and how this is to be accomplished. It establishes a framework with defined procedures
and practices to ensure that the completed product meets or exceeds the project specified quality
requirements.
QA Process: Quality assurance (QA) is defined as the process or procedure the contractor will
engage in to ensure that the required quality of the project is achieved. This process defines the
inspection requirements, the timing of the inspections, written report, and who is to receive and
review them, and in the event that any need for correction who and how it will be done, with the
appropriate defined follow up.
Managing Quality
Quality Assurance Personnel: The role of the quality assurance personnel is to ensure that the
quality control program is functioning properly and its intent is carried out diligently.
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QA Procedures: Review adequacy of the quality assurance plan:
 Determine if the work practices are such that the expected quality standard will be met.
 Examine the quality of the ongoing and completed work to determine that it meets or exceeds
the project requirements.
 Ensure that the material used meets project quality standards.
 The finished work is sufficiently protected from harm or damage.
 Issue a report of acceptable work as well as any substandard work.
 Track the corrective work and issue status report until satisfactory completion.
 Examine the quality control methods being used to determine if the supervisor is properly
controlling construction activities.
 Review processes, practices and procedures. and identify possible areas for change so as to
improve the quality of the resulting work
 Recommend any changes to project staff and/or management.
 Review QC documentation to ensure adequacy of systems.
Project Quality Management

Project management consists of four main processes:
Quality Definition
Quality Assurance
Quality Control
Quality Improvements
Quality Characteristics
All material or services have characteristics that facilitate the
identification of its quality. The characteristics are part of the
conditions of how the material, equipment and services are able to
meet the requirements of the project and are fit for use by the
beneficiaries. Quality characteristics relate to the attributes, measures
and methods attached to that particular product or service.
 Functionality is the degree, by which equipment performs its

intended function, this is important especially for clinical equipment,
that the operation should be behave as expected.
 Performance, its how well a product or service performs the
beneficiaries intended use. A water system should be designed to
support extreme conditions and require little maintenance to reduce
the cost to the community and increase its sustainability.
 Reliability, it’s the ability of the service or product to perform as
intended under normal conditions without unacceptable failures.
Material used for blood testing should be able to provide the
information in a consistent and dependable manner that will help
identify critical diseases. The trust of the beneficiaries depend on the
quality of the tests
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 Relevance, it’s the characteristic of how a product or service meets
the actual needs of the beneficiaries, it should be pertinent,
applicable, and appropriate to its intended use or application
 Timeliness, how the product or service is delivered in time to solve
the problems when its needed and not after, this is a crucial
characteristic for health and emergency relief work
 Suitability, defines the fitness of its use, it appropriateness and
correctness, the agriculture equipment must be designed to operate
on the soul conditions the beneficiaries will use it on.
 Completeness, the quality that the service is complete and includes
all the entire scope of services. Training sessions should be complete
and include all the material needed to build a desired skill or
knowledge
 Consistency, services are delivered in the same way for every
beneficiary. Clinical tests need to be done using the same procedure
for every patient.
Quality characteristics must be included in all material, equipment and

services the project will purchase, the procurement officers must have
a complete description of what is required by the project, otherwise a
procurement office may purchase the goods or services based on her
or his information of the product.
Quality plan
Part of defining quality involves developing a quality plan and a quality
checklist that will be used during the project implementation phase.
This check list will ensure the project team and other actors are
delivering the project outputs according to the quality requirements.
The quality plan also describes the conditions that the services and
materials must possess in order to satisfy the needs and expectations
of the project stakeholders, it describes the situations or conditions
that make an output fall below quality standards, this information is
used to gain a common understanding among the project team to help
them identify what is above and what is below a quality standard.
The quality plan also includes the procedure to ensure that the quality
standards are being followed by all project staff. The plan also includes
the steps required to monitor and control quality and the approval
process to make changes to the quality standards and the quality plan.
QUALITY ASSURANCE
Assurance is the activity of providing evidence to create confidence
among all stakeholders that the quality-related activities are being
performed effectively; and that all planned actions are being done to
provide adequate confidence that a product or service will satisfy the
stated requirements for quality.
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Quality Assurance is a process to provide confirmation based on
evidence to ensure to the donor, beneficiaries, organization
management and other stakeholders that product meet needs,
expectations, and other requirements. It assures the existence and
effectiveness of process and procedures tools, and safeguards are in
place to make sure that the expected levels of quality will be reached
to produce quality outputs.
Quality assurance occurs during the implementation phase of the
project and includes the evaluation of the overall performance of the
project on a regular basis to provide confidence that the project will
satisfy the quality standards defined by the project.
Quality Audits
Quality audits are structured reviews of the quality management
activities that help identify lessons learned that can improve the
performance on current or future project activities.
Audits are
performed by project staff or consultants with expertise in specific areas. The purpose of quality
audit is to review how the project is
using its internal processes to produce the products and services it will
deliver to the beneficiaries. Its goal is to find ways to improve the
tools, techniques and processes that create the products and services.
The proper level of maturity to which an organization should strive is

determined during a detailed assessment conducted by a professional
project management consulting team. The organization has achieved
full project management maturity when it has met the requirements
and standards for project management effectiveness and it is capable
of demonstrating improvements such as on-time project delivery, cost
reductions, organizational efficiency, and quality outcomes.
A project quality maturity usually consists of five levels:
 Level 1. Informal level, there is no defined processes for quality

practices or standards. The organization may be in the initial stages
of considering how projects should define quality, but most efforts
are informal and had-oc.
 Level 2. Defined level, the organization has defines some basic
quality standards and project quality policies that are being adopted.
But not all projects are using it in a consistent manner.
 Level 3. Repeatable level, the quality process is well documented
and is an organizational standard. All projects are using it and
producing consistent and repeatable results.
 Level 4. Controlled level, all projects required to use quality
planning standard processes. The organization has a unit or roles
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that coordinate quality standards and assurance and quality audits
are done on a regular basis.
 Level 5. Optimized level, the quality process includes guidelines for
feeding improvements back into the process. Metrics are used as key
criteria for quality decisions and quality results are predictable.
Quality Management Process Outline:
Introductory Statement
1. Program Elements
 Policy and Procedures
 Goals and Objectives
 General Quality Management
 Roles and Responsibilities
 Approvals and Reviews
 Document Control
 Process Improvement
 Project-Specific Quality Management Plan
2. Preconstruction (some activities may not apply)
 Review of Plans and Specifications
 Quality standards
 Review Requirements
 Clarify Any Ambiguity
 Samples or Mockups
 Constructability Reviews
 Documenting Existing Conditions
 Material Management
 Transportation Factors
 Receiving at the Jobsite
 Storage and Protection
 Subcontractor factors
 QA/QC Program
 Field Procedures
 Fabrication Shop Inspections
 Testing
 Requirements
 Procedures
 Documentation
3. Construction Operations
 Zero Defect Program
 Quality Assurance Administration
 Roles and Responsibilities
 Inspection and Testing Plan
 Inspection Checklists
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 Quality Assurance(QA) Process
 Specified Quality Requirements
 QA Process
 Pre-Installation Meeting and Inspection
 First Work-in-Place Meeting and Inspection
 Follow-Up or Daily Inspections
 Inspections
 Inspection schedule
 Pre-Cover-Up and Pre-Closure Inspections
 Documentation
 Written Report
 Digital Pictures
 Nonconformance Procedures
 Report
 Tracking
 Correction
 Material Verification
 Water Intrusion Prevention
 Preconstruction
 Inspections During Construction
 Protection of the Work
4. Closeout
 Closeout Procedures
 As Built
 Punch List Work Management
 Systems Turnover Practices

 Startup
 Testing of Systems
 Training of Personnel
 Documentation
 O&M Manuals
 Final Acceptance
5. Post construction
 Warranties
 Warranty Management During the Warranty Period
 Warranty Callbacks after the Warranty Period
 Resulting Damage
 Post construction Documentation
6. Abbreviations
7. Glossary of Terms
8. References
9. Attachments
 Meeting Documentation
 Preconstruction Meeting Agenda
 Pre-installation Meeting Minutes
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 First Work-in-Place Meeting Minutes
 Reports
 Daily Quality Control Inspection Report
 Subcontractor's Daily Quality Control Inspection Report
 Nonconformance Report
 Checklists
 Construction Site Inspection Checklist
 Preclusive Inspection Form
 Logs
 Inspection and Testing Log
 Nonconformance Report Log
 Digital Photo Log
 Warranty Work Log
 Sample Plans
Subcontractor's Site Specific Quality Control Plan

Inspection and Testing Plan

Water Intrusion Management Plan

 Sample Punch List
Conclusion
A contractor must have a robust quality management program as it is critical to the overall
success of a construction project. An effective program creates a process for clarifying standards
and requirements, established means and methods for managing the process, defines
responsibilities and accountabilities, and adds another avenue to more effectively manage the
supply chain, while it reduces misunderstanding and potential conflict. It effectively facilitates
and manages the collection of data, identifies performance discrepancies and nonconforming
work, and substantially increases efficiency by reducing defects and punch list work, which aids
in. improving the working relationship with the design team and the project owner. It
systematically manages quality and enhances the contractor’s project delivery, increases
productivity, eliminates or reduces waste, and ultimately improves profitability.
Here are 6 steps to develop a quality control process:
1. Set your quality standards.
In some industries, you may have to meet quality standards set by an outside body, such as an
industry association, the local health and safety inspector, or a government regulatory agency. In
others, there aren't any official quality standards, so you'll need to set your own.
Each department of your business will have different quality control standards. However, they
must all be objectively measurable. For example, if you're developing quality control standards
for your customer service team, “sounding friendly on the phone" is not a measurable standard.
Measurable standards might include:
 Answering all customer calls by the second ring

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 Responding to all customer service emails within four hours
 Resolving customer service problems in five minutes or less
2. Decide which quality standards to focus on.
Of course, you want to ensure quality in all aspects of your operation. However, begin by
focusing on the most important measures — those that have the biggest effect on your profits and
your customer experience. This will enable you to get results quickly and also keeps you and
your team from becoming overwhelmed.
For instance, if you own a restaurant, keeping the restrooms clean is definitely something to
monitor in your quality control program—but not the most important thing. Getting orders out to
customers quickly and accurately is a more important standard because it has a more direct effect
on the quality of experience and customer satisfaction.
3. Create operational processes to deliver quality.
W. Edwards Deming, the founder of modern quality control, believed that well-designed
processes lead to high-quality products and services. If you create good processes, continually
measure the results of the processes, and work to consistently improve the process, your product
or service will get better and better.
Starting with your critical operations, create step-by-step processes that include benchmarks. For
instance, in a B2B company's accounting department, operational processes might require
preparing and delivering invoices within 24 hours after a job is completed or a product is
delivered. In a restaurant, operational processes might require servers to pick up food for
delivery to the customer’s table within two minutes of it being prepared.
4. Review your results.
Most business software, from financial and accounting apps to customer relationship
management or customer service tools, lets you customize the information you collect and use
dashboards to view it at a glance. Review your data regularly to see how well your company is
meeting its quality standards.
5. Get feedback.
Use measurable feedback from external sources, such as customer surveys, online ratings and
reviews and net promoter scores (NPS), to get a fuller picture of product and service quality.
Also, get regular feedback from employees. How well are the operational processes working to
deliver quality? How could they be improved?
6. Make improvements.
Once you’re meeting your quality control standards, don't stop there. For example, if you own a
residential cleaning service business and you can cut the time it takes your maids to clean a home
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by 25 percent, you’ll be able to handle 25 percent more business without hiring any
employees. That will really boost your bottom line.
No matter how well your processes are running, quality control shows there's always room for
improvement, and making small changes can pay off in big ways.
PROJECT QUALITY MANAGEMENT
Quality management is the process for ensuring that all project activities necessary to design,
plan and implement a project are effective and efficient with respect to the purpose of the
objective and its performance. Project quality management (QM) is not a separate, independent
process that occurs at the end of an activity to measure the level of quality of the output. It is not
purchasing the most expensive material or services available on the market. Quality and grade
are not the same, grade are characteristics of a material or service such as additional features. A
product may be of good quality (no defects) and be of low grade (few or no extra features).
Quality management is a continuous process that starts and ends with the project. It is more
about preventing and avoiding than measuring and fixing poor quality outputs. It is part of every
project management processes from the moment the project initiates to the final steps in
the project closure phase. QM focuses on improving stakeholder’s satisfaction through
continuous and incremental improvements to processes, including removing unnecessary
activities; it achieves that by the continuous improvement of the quality of material and services
provided to the beneficiaries. It
is not about finding and fixing errors after the fact, quality
management is the continuous monitoring and application of quality
processes in all aspects of the project.
Definition of Quality
Quality has been defined as "the totality of characteristics of an entity
that bear on its ability to satisfy stated or implied needs."1 The stated
and implied quality needs are the inputs used in defining project
requirements from the donor and the beneficiaries. It is also defined
as the “Conformance to requirements or fitness for use”2; which
means that the product or services must meet the intended objectives
Quality assurance & Quality control
Quality assurance (QA) and quality control (QC) are two terms that are often used
interchangeably. Although similar, there are distinct differences between the two concepts. This
page will explain the differences between quality control and quality management, and provide
definitions and examples of each.
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Quality System, Quality Assurance, and Quality Control Relationships
Differences between QA and QC
Quality assurance and quality control are two aspects of quality management. While some
quality assurance and quality control activities are interrelated, the two are defined differently.
Typically, QA activities and responsibilities cover virtually all of the quality system in one
fashion or another, while QC is a subset of the QA
activities. Also, elements in the quality system might
not be specifically covered by QA/QC activities and
responsibilities but may involve QA and QC.
See training courses for these crucial functions:
Quality Assurance
Quality assurance can be defined as "part of quality

management focused on providing confidence that
quality requirements will be fulfilled." The
confidence provided by quality assurance is twofold—internally to management and externally
to customers, government agencies, regulators, certifiers, and third parties. An alternate
definition is "all the planned and systematic activities implemented within the quality system that
can be demonstrated to provide confidence that a product or service will fulfill requirements for
quality."
Quality Control
Quality control can be defined as "part of quality management focused on fulfilling quality

requirements." While quality assurance relates to how a process is performed or how a product is
made, quality control is more the inspection aspect of quality management. An alternate
definition is "the operational techniques and activities used to fulfill requirements for quality."
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Industry Perspectives on QA and QC
For some service organizations, the concept of quality control may be foreign because there is no
tangible product to inspect and control. The quality assurance function in a service organization
may not include quality control of the service but may include quality control of any products
involved in providing the service.
A service may include products that are documents (such as a report, contract, or design) or
tangible products (such as a rental car or units of blood). It may be necessary to control product
quality in a service organization to ensure that the service meets customer requirements.
QA, QC, and Inspection
Inspection is the process of measuring, examining, and testing to gauge one or more
characteristics of a product or service and the comparison of these with specified requirements to
determine conformity. Products, processes, and various other results can be inspected to make
sure that the object coming off a production line, or the service being provided, is correct and
meets specifications.
Quality Assurance and Audit Functions
Auditing is part of the quality assurance function. It is important to ensure quality because it is
used to compare actual conditions with requirements and to report those results to management.
In The Quality Audit: A Management Evaluation Tool (McGraw-Hill, 1988), Charles Mill wrote
that auditing and inspection are not interchangeable: “The auditor may use inspection techniques
as an evaluation tool, but the audit should not be involved in carrying out any verification
activities leading to the actual acceptance or rejection of a product or service. An audit should be
involved with the evaluation of the process and controls covering the production and verification
activities.”
Formal management systems have evolved to direct and control organizations. There are quality
management systems (QMSs) as well as environmental or other management systems, and each
of these systems may be audited.
History of QA and QC
Quality has been defined as fitness for use, conformance to requirements, and the pursuit of
excellence. Even though the concept of quality has existed from early times, the study and
definition of quality have been given prominence only in the last century.
Quality Control
Following the Industrial Revolution and the rise of mass production, it became important to
better define and control the quality of products. Originally, the goal of quality was to ensure that
engineering requirements were met in final products. Later, as manufacturing processes became
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more complex, quality developed into a discipline for controlling process variation of
producing quality products.
Quality Assurance and Auditing
The quality profession expanded to include the quality assurance and quality audit functions. The
drivers of independent verification of quality were primarily industries in which public health
and safety were paramount.
What are the four main elements of quality?

Quality management ensures that an organization, product or service is consistent. It has four
main components: quality planning, quality assurance, quality control and quality
improvement. Quality management is focused not only on product and service quality, but also
on the means to achieve it.
What are the 7 key principles of quality?

The seven quality management principles are:
 Customer focus.
 Leadership.
 Engagement of people.
 Process approach.
 Improvement.
 Evidence-based decision making.
 Relationship management.
What are the elements of quality?

The elements of a QMS should include quality objectives, a quality manual, organizational
responsibilities, data management, and other practices.
 Quality Objectives. ...

 Organizational Structure and Responsibilities. ...
 Data Management. ...
 Processes. ...
 Customer Satisfaction with Product Quality. ...
 Continuous Improvement.
What are the key elements of TQM?

The Eight Elements of TQM
 Ethics.
 Integrity.
 Trust.
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 Training.
 Teamwork.
 Leadership.
 Recognition.
 Communication.
A Quality Management System is a set of business processes which are implemented to help an
organization deliver products which consistently achieve customer satisfaction. An effective
system for managing quality translates an organization's purpose and goals into policies and
resources which help every member of the organization adopt standard operating procedures
(SOPs). The use of management frameworks to ensure consistent quality isn’t a new concept, but
the purpose of quality systems has evolved slightly in recent years.
The widespread use of the phrase "Quality Management System" and the commonly used
acronym of "QMS" can be traced to British Management Consultant Ken Croucher, who created
a model for Total Quality Management (TQM) in tech organizations. Croucher’s model was
informed by best practices for quality management in manufacturing organizations in the 20th
century, including the earliest applications of statistical sampling methods to ensure consistency.
Early models for TQM focused on an interdisciplinary approach to reducing waste, such as
avoidable labor costs.
Process efficiency isn’t the only benefit of Quality Management Systems today. Organizations
use QMS frameworks to guide continuous improvement efforts and adopt data for evidence-
based decision making. Organizations in highly regulated industries seek certification with
globally recognized standards such as ISO 9001 to improve quality through transparency,
documentation, and systemic approaches to improvement. The adoption of Quality Management
Software typically supports modern QMS.
Adopting a QMS can support compliance, profitability, and the development of a quality-driven
culture. While there are numerous QMS standards, the best-known systems for total quality
management all represent a comprehensive framework for the quality-driven organization.
Organizations must adopt an interdisciplinary series of quality controls to achieve these

principles. The nine core elements of a QMS should include quality objectives, a quality manual,
organizational responsibilities, data management, and other practices.
1. Quality Objectives
The creation of quality objectives is a common requirement of QMS standards, including ISO
9001. These objectives are designed to encourage organizations to define strategic goals and a
purpose for the QMS. Objectives translate an organization’s vision into practice by creating a
link between customer requirements and specific, measurable, and attainable goals. Well-written
objectives lend purpose to a QMS initiative and establish a customer-centric culture in an
organization.
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A pharmaceutical startup in the research phase may have identified a customer need
affordable therapeutics to treat a common skin condition. Since the product is being developed,
the organization may create a quality policy with a stated goal "To develop a safe, effective
treatment for eczema patients which is available at a lower cost than alternatives."
Quality objectives for this organization could include:
 To obtain total compliance with staff training requirements and raise average assessment
scores from 90% to 95%.
 To successfully implement a QMS software within three months and eliminate paper and
spreadsheet-based record keeping methods within six months.
 To achieve a successful initial synthesis of the drug and complete all necessary processes
for FDA initial review within 12 months.
Quality objectives should provide a clear vision for every member of the organization to
understand the company's purpose and the value of a QMS. The objectives should provide a clear
metric for measuring progress against strategic goals, including the timeline for achievement and
a measurable parameter of improvement.
Key Elements
TQM has been coined to describe a philosophy that
makes quality the driving force behind leadership,
design, planning, and improvement initiatives. For
this, TQM requires the help of those eight key
elements. These elements can be divided into four
groups according to their function. The groups are:
I. Foundation – It includes: Ethics, Integrity and
Trust.
II. Building Bricks – It includes: Training,
Teamwork and Leadership.
III. Binding Mortar – It includes: Communication.
IV. Roof – It includes: Recognition.
I. Foundation
TQM is built on a foundation of ethics, integrity and
trust. It fosters openness, fairness and sincerity and
allows involvement by everyone. This is the key to unlocking the ultimate potential of TQM.
These three elements move together, however, each element offers something different to the
TQM concept.
Ethics – Ethics is the discipline concerned with good and bad in any situation. It is a two-
faceted subject represented by organizational and individual ethics. Organizational ethics
establish a business code of ethics that outlines guidelines that all employees are to adhere to in
the performance of their work. Individual ethics include personal rights or wrongs.
What are the skills required for quality control?

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Key skills for quality assurance managers
 Confidence.
 Excellent technical skills.
 Good numerical skills and an understanding of statistics.
 Leadership skills.
 Planning and organization skills.
 Communication and interpersonal skills.
 Problem-solving skills.
 Team working skills
What are three responsibilities of a quality control specialist?

Quality Control Specialist Duties and Responsibilities
 Conduct Product Tests and Assessment. The main duty of a quality control specialist is
testing and assessing products, usually in an industrial or warehouse setting. ...
 Identify Product Defects. ...
 Record and Report Issues. ...
 Support Process Improvements. ...
 Make Necessary Repairs.
What skills do you need to be a quality assurance?

Traditionally, in order to fulfill these responsibilities, a quality assurance manager would
need to be proficient in a number of skills including:
 Leadership.
 Organizational and planning.
 Communication.
 Statistical analysis.
 Problem-solving.
 Industry-specific technical knowledge.
What are the pillars of TQM?

His book, occasionally slowed by overstatements of the same points, still makes a highly
persuasive case for any organization to start TQM immediately, relying on its interdependent
"five pillars": product, process, organization, leadership, and commitment.
What are the 5 elements of QAPI?
 Five Elements.
 Element 1: Design and Scope.
 Element 2: Governance and Leadership.
 Element 3: Feedback, Data Systems and Monitoring.
 Element 4: Performance Improvement Projects (PIPs)
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 Element 5: Systematic Analysis and Systemic Action
What come first QA or QC?

Quality control helps you find defects in the deliverable and correct them. Quality assurance is
a proactive process which starts even before the work on the deliverable has started, while
quality control is a reactive process and its activity starts as soon as you start working on the
deliverable.
Quality assurance
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products
and avoiding problems when delivering products or services to customers; which ISO 9000
defines as "part of quality management focused on providing confidence that quality
requirements will be fulfilled".[1] This defect prevention in quality assurance differs subtly from
defect detection and rejection in quality control and has been referred to as a shift left since it
focuses on quality earlier in the process (i.e., to the left of a linear process diagram reading left to
right).[2]
The terms "quality assurance" and "quality control" are often used interchangeably to refer to
ways of ensuring the quality of a service or product.[3] For instance, the term "assurance" is often
used as follows: Implementation of inspection and structured testing as a measure of quality
assurance in a television set software project at Philips Semiconductors is described.[4] The term
"control", however, is used to describe the fifth phase of the Define, Measure, Analyze, Improve,
Control (DMAIC) model. DMAIC is a data-driven quality strategy used to improve processes.
Quality assurance comprises administrative and procedural activities implemented in a quality

system so that requirements and goals for a product, service or activity will be fulfilled.[3] It is the
systematic measurement, comparison with a standard, monitoring of processes and an associated
feedback loop that confers error prevention. This can be contrasted with quality control, which is
focused on process output.
Quality assurance includes two principles: "Fit for purpose" (the product should be suitable for
the intended purpose); and "right first time" (mistakes should be eliminated). QA includes
management of the quality of raw materials, assemblies, products and components, services
related to production, and management, production and inspection processes. The two principles
also manifest before the background of developing (engineering) a novel technical product: The
task of engineering is to make it work once, while the task of quality assurance is to make it
work all the time.
Historically, defining what suitable product or service quality means has been a more difficult
process, determined in many ways, from the subjective user-based approach that contains "the
different weights that individuals normally attach to quality characteristics," to the value-based
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approach which finds consumers linking quality to price and making overall conclusions of
quality based on such a relationship
10 ways to maintain consistent project quality
1. Define quality
2. Commit to quality
3. Stick to project requirements
4. Manage quality
5. Perform quality assurance
6. Control the quality
7. Focus on requirements
8. Follow project processes
9. Document lessons learned
10. Take time for a through project de-brief
Maintaining consistent project quality takes commitment, focus and courage, and following these
steps will not only help you maintain high levels of quality in projects but also continuously
improve the consistency of quality in your projects. To learn more about how Hydra Cloud can
help you maintain and improve the consistency of quality in your projects, download our
brochure or get in touch for a free, no obligation consultation.
10 ways to maintain consistent project quality
Quality matters! Quality separates the professional from the amateur and it takes commitment,
focus and sometimes courage, to maintain consistent project quality and deliver it within budget.
When you're delivering a multi-million-pound IT project, poor project quality can have profound
effects, resulting in re-work, schedule delays, higher cost, frustration, morale problems, and lack
of customer satisfaction. So how can you ensure that you maintain consistent project quality
from start to finish?
1. Define quality
Quality is ambiguous, it can mean many things. For example, The Project Management Body of
Knowledge (PMBOK) defines quality as, “conformance to requirements and fitness of use”, ISO
9000 defines quality as, “the degree to which a set of inherent characteristics fulfill requirement".
Whatever type or size of project you are managing, take the time to define the quality criteria for
your current work so that your team members understand what it is, and how to reach and
improve upon it.
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2. Commit to quality
A company's commitment to quality must come from the top and be reinforced repeatedly.
Unless a Business views quality as its single, non-negotiable goal, workers will inevitably feel
the need to make trade-offs and quality will slip.
As a project manager or leader, commit to quality, share the commitment with your staff and
think about how you will handle the any conflict between your stated objective and an attractive
cost-saving, short cut that compromises quality.
3. Stick to the project requirements!
Once you’ve defined the quality criteria and project requirements, stick to them! Balance
continual project improvements with gold-plate requirements. Adding features the customer did
not request increases the potential for delays, and higher cost. Project Managers drive
improvements and project quality but beware of out-of-scope extras creeping in.
4. Manage quality
Work with your project team to define a practical approach to managing quality, including
applicable standards and quality processes.
5. Perform quality assurance
Execute your quality management plan using the standards and processes defined in the project
blueprint. Perform a quality audit to evaluate how well the team is following the plan and
meeting your customer’s expectations.
6. Control the quality
Ensure the deliverables are correct and free of defects and focus on quality from the beginning to
the end of the project. Perform inspections to identify defects. Start as early as possible;
identifying and correcting defects close to the point of origin saves time and money.
7. Focus on requirements
Requirements management and quality management go hand in hand. Clear, well-defined

requirements lead to less rework and schedule delays. Focus on improving the requirements
process—eliciting, analyzing, documenting and validating them.
8. Follow the project processes
Follow the processes and tasks contained in your project blueprint. If you identify a more
efficient way to do something, add this into the blueprint to continually improve the processes.
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9. Lessons learned
Document lessons learned after project phases and at the completion of the project to evaluate
your processes and ‘bake’ all the improvements into the project blueprint and translate them to
future projects. This forms part of your knowledge management strategy; you build up a
knowledge bank and use lessons learned in the last project for both existing and new projects.
10. Project De-Brief
The project de-brief is more than a casual conversation about what did and didn’t work, it digs
into why things happened (or didn't happen). A de-brief can sometimes be as painful as the
project itself, especially when your project has failed, and you need to investigate where things
went wrong. Rather than rushing headlong into your next project take time for a thorough de-
brief with both your team and your client so that over time you continuously improve the
consistency of quality in your projects and deliver more of them successfully.
Quality Assurance Manager
The company Quality Assurance Manager is the representative of the project and has the
responsibility for the implementation and maintenance of the quality management system.
Role Responsibilities
 The preparation of the companies QA manual control and supervision of all amendments
and revisions
 Control and the distribution of all the companies quality documentation
 Monitor all quality related activities on the project
 Perform all internal and external audits on behalf of the company’s management
 Verify contractor quality requirements are specified to vendors and contractor
documentation submittals.
 Attend all pre-bid meetings and coordinate all project requirements with the project
bidders.
 Attend client quality management meetings
 The preparation and control of project quality system management documentation prior
to project commencement.
 Review quality inspection personnel qualifications and training requirements
 Monitor the disposition of all issued nonconformance reports.
 Monitor the progress and effectiveness of the project quality management system.
Recommend and implement improvements when required.
 Coordinate all QA/QC activities with the site QC manager
 Coordinate all QA/QC activities with the site QA/QC procurement manager
 Coordinate all quality related correspondence with the customers representatives.
 Monitor statistical method reporting.
 Action and close all customer complaints
 Control all achieve documentation upon the completion of the project.
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Quality Assurance Quality Control Procurement Management
The quality control procurement manager has the responsibility for the coordination and
inspection of all procured items for site. He is responsibility to the projects QA manager.
 The reviewing of site purchase orders to ensure that the applicable requirements are met
 The control of on site and off site vendor inspectors
 The compilation of vendor inspection assignments packages
 The coordination and resolution of any nonconforming product Reviewing vendors QA/QC
systems in accordance with contractual requirements
 The attendance at site and inspection procurement meetings
 Coordination of vendor quality approvals when required
 Ensure the verification of documentation and certificates for materials purchased by vendors
 Review of suppler quality plans against contract requirements
 Review procurement documents to ensure that quality requirement have been correctly
translated into purchase requisitions and design documents
 Review supplier inspection procedures and personnel qualifications
 Review supplier material certificates
 Take part in supplier audit and surveillances
 Coordinate with the companies discipline engineers for the resolution of technical
discrepancies
 Coordinate with management for quality improvements
 Issue of nonconformance reports
 Track all nonconformance reports
 Coordinate with the owners representative on all procurement issues
 Monitor progress of all purchase requisitions
Quality Assurance Quality Control Manager (Site)
The company site Quality Control Manager reports to the company QA Manager. He ensures the
quality of the site installations is consistent with the company’s policy requirements together
with national and international standards and the customers specifications.
 Implement the QA/QC management system at site

 Coordinate with quality inspections with all the site sub contractors and vendors coordinate
all non destructive testing on site
 Coordinate with the customers representative on all quality matters
 Coordinate all receipt inspections
 Distribute relevant QA/QC documentation to site subcontractors
 Verify that the quality related site activities are in accordance with the applicable codes and
standards
 Participate in the site internal and external site audits
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 Coordinate all the quality site inspections through the site QC inspectors
 Ensure all quality control documentation is complied and competed for as-built hand over
through the QC turnover engineer
 Control all nonconformance reports and undertake remedial action
 Compete site quality control instructions and action remedial responses
 Review the customers specification and undertake relevant training to the site QC inspector
 Monitor the implementation of the approved site QC Plan
 Complete and coordinate the approval of the sites QC technical submittals to the customer
 Coordinate with the site construction manager on all quality issues Coordinate and chair the
QA/QC site weekly meetings with the projects subcontractors QC personnel
 Elaborating inspection and test programs
 Ensure the safety is adhered to at site
 Assure all technical documents relative to site quality control are current status
Quality Control Turn Over Engineer
The QA/QC Turnover engineer reports to the site QA/QC manager. He is responsible for the
following.
 Ensures the quality records, acceptance certificates, mechanical completion certificates and
the documentation for specific systems and buildings/areas are prepared and collated in
accordance with project requirements
 Coordinate with the planning and scheduling department to ensure milestone dates are
understood for each turn over area
 Coordinate with the site QC manager for the completion of as-built turnover documentation
 Resolve any discrepancies between the completed milestone and quality documentation
 Review suppliers inspection and test plans against the milestone scope of work
 Coordinate with the commissioning department to define the scope of work
 Assist the site subcontractors to compile turnover dossiers
 Provide progress information for incorporation into project reports
 Monitor hydrostatic test packs for incorporation into as-built dossiers
 Consider the implications of delays in QC as-built turnover documentation and bring to the
attention of the site QC manager
 Monitor and control the status of punch list and exception lists relevant to quality dossiers
 Attend the weekly QA/QC, and commissioning meetings
 Coordinate any inconsistencies with test packages with the field QC site inspectors
 Provide progress data to the planning and scheduling department
QC Senior Welding Inspector
The QC senior welding inspector reports to the site QC manager. He is responsible for the
following.
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 Elaborating and coordinating the welding specifications, and codes/standards

 Coordination with the field subcontractors for all welding procedure specifications and
procedures qualifications reports
 Review course and effects of welding defects and take remedial actions
 Coordination with the field subcontractors and the Third Party NDT Inspection Company
 Review of the radiographic film and all NDT reports on a daily basis
 Auditing of the approved Third Party NDT Inspection Company
 Reviewing the inspection and testing methods and procedures for Radiographic, Dye
Penetrant, Magnetic Particle, and Ultrasonic inspections
 Witnessing of welder qualifications testing and procedures qualification testing
 Witnessing any remedial repair welding
 Reviewing of the welding summery reports
 Checking the hydrostatic test packages for NDT compliance prior to testing
 Advising the site subcontractors with regards to welding and testing
 Monitor any Post Weld Heat Treatment on site and review the completed test reporting
 Selection of welds for non destructive testing
 Recording and listing of defective welds
 Monitor the control and issue of welding electrodes
 Control the QC site welding inspectors
 Actively monitor site radiation safety
 Review day to day applications for x-raying of welds
 Coordinate the issue of nonconformance reports through the site QC manager
 Compete site quality instructions to sub contractors when required
Quality Control Discipline Site Inspectors
Welding, Mechanical, Piping, Painting, Electrical, Instrumentation; Civil & Structural) The site
QC inspectors reports to the site QC manager
 Witnessing and sentencing of all site inspections within their disciplines

 Coordinate all site inspections with the site subcontractors
 Ensure that all inspection reports are accurate and that all attached documents are current
status
 Ensure all work is correctly prepared prior to any inspection being undertaken
 Review all inspection reports for compliance
 Assist the site QC manager in the organisation, maintenance and control of the quality
system
 Liase with the site construction engineers and provide assistance when requested
 Prepare nonconformance reports to the QA manager and assist in developing corrective
actions
 Assist the QC manager and construction manager in resolving any discrepancies and
ambiguities
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 Coordinate with the customers QC inspectors for the resolution of site problems
 Coordinate with the site subcontractors to ensure that communications exist and are
maintained
 Assist the site subcontractors in the resolution of drawing interpretation
 Attend the weekly QC meetings
 Review work procedures and method statements for compliance with good work practices
and the customers contract specializations
 The issuance of nonconformance reports in conjunction with the site QC manager
 The completion of QC site instructions and coordinate their closure The review of inspection
test packages during the course of construction activities
 Compliance with the site’s health and safety regulations
Certification Engineer
 Facilitate the coordination of required verification information between the Client

Representative, Client and project personnel.
 Ensure the integrity and legal compliance of the product by engaging, and working with,
Client Representative, Client and project personnel..
 Provide advice and guidance to the project delivery team on all matters of verification and
regulatory compliance
 Work with the Location Quality Manager and the Project Management Team to ensure:
 Project Verification Plan and dependent systems and procedures are developed and
implemented in compliance with the requirements of the Quality Management System
(QMS) and Project Management System (PMS) consistent with specific location, regulatory
and contractual requirements.
 Project personnel are suitably trained in Project Verification Plan requirements and to access
and apply dependent systems, procedures and reference materials via the Project Web Site,
QMS, PMS and the Knowledge Communities as applicable. Facilitate regular meetings with
all interested parties to ensure alignment of understanding and direction.
 Co-ordinate the implementation of certification assurance processes within the project for
regulatory compliance
 Review and approve Supplier/Subcontractor Quality Control Plans/Inspection Test plans and
procedures.
 Be familiar with the requisition requirements and equipment/material specifications.
 Be fully familiar with the verification and inspection release processes and ensure their
compliance.
 Ensure all certification requirements are clearly identified, understood and included with the
requisition and PO.
 Attend Pre-production kick-off meetings with Supplier/Subcontractor (as appropriate).
 Review Supplier/Subcontractor Fabrication/Certification Dossiers (as appropriate).
 To participate (as necessary) in management visits/audits to Suppliers and Sub-contractors.
 Report promptly to the Project Quality Manager all matters related to verification scheme
performance and regulatory compliance.
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 Ensure that all necessary quality records are identified and retained in accordance
and regulatory requirements.
Audit Leader
The Audit leader will ensure the implementation and effectiveness of quality processes and
procedures that are required to assure integrity of the company assets throughout their Asset
Lifecycle, FEED (Front End Engineering & Design) EPC (Engineering Procurement &
Construction) Precommissioning, Commissioning and Project Handover.
The Audit leader will assist the Asset Integrity Manager with the following:
 Confirm that all the necessary strategies and controls are demonstrably in place to assure the
integrity of the assets in the operations/production phase of the full lifecycle.
 Confirm project processes and procedures have been implemented to demonstrate full
compliance with the governmental integrity related laws
 Confirm that the impact of the rapidly evolving governmental legislative framework on the
(Production) Integrity Assurance Strategy is properly managed
 Confirm that the facilities under development, designed and built by the Project teams, are
managed in such a way that integrity (and hence safety and economic performance) can be
maintained during the full asset lifecycle
 Confirm that the Project teams have made adequate integrity assumptions in the development
of the basis of project design, operational strategies and maintenance strategies
 Provide guidance in the development of Integrity Assurance processes and procedures of
related projects as required
 Provide discipline driven input to the development of the overall asset integrity assurance
plan for the onshore and offshore assets
 Translate discipline focussed systems and management processes within the asset integrity
assurance plan into actionable procedures and work instructions for independent audit teams
 Foster and mentor a regionalization programmer for the integrity assurance function, building
sustainable competency and a sustainable integrity assurance & safety culture among newly
recruited project staff
Accountabilities and Responsibilities:
The Audit Leader is responsible for:
 Assisting the Asset Integrity Assurance Manager by acting as audit leader of assigned audits
(the audit leader will preferably be assigned to audits of his own technical expertise)
 Managing exercises and audits to ensure the necessary strategies and controls are
demonstrably in place to assure the integrity of the assets in all phases of the project lifecycle
 Contributing to the assurance that the facilities under development by the Company are
designed and built in such a way that integrity (and hence safety and economic performance)
can be maintained during all phases of the lifecycle
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 Contributing to the preparation of look ahead plans for audits to be held
 Managing external resources in the execution of audits
 Coordinating with other auditing teams to prevent unnecessary disturbance of running
projects
 Reviewing agendas and terms of reference to ensure clarity of purpose
 Preparing external parties of the auditing team for the audit
 Compiling and issuing report and support interpretation of its contents; follow-up and
monitor closure of actions
 Coordinating reporting of external parties
HSE Responsibilities:
 Assuring technical integrity forms the basis of the company’s health, safety and
environmental performance.
 Audit Leader will interface with the on- and offshore Construction and Commissioning-, to
plan and organise audits.
 Audit Leader will interface with representatives of the non-operating partners with regards to
performing the auditing functions
 Audit Leader will interface with representatives of integrity related contractors performing
auditing tasks for the Asset Integrity Assurance Group.
Protecting your investment through quality management system assurance in accordance

with (International Standard Organisation) ISO9001
 Giving project owners assurance that they are obtaining a quality product
 Construction project quality assurance provides the customer with confidence
 Protecting milestone payments, providing customers with evidence that the work carried out
meets acceptance criteria
LO2
Hazard analysis and critical control points, or HACCP (/ˈhæsʌp/[citation needed]), is a systematic
preventive approach to food safety from biological, chemical, physical hazards and more
recently radiological hazards in production processes that can cause the finished product to be
unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP
attempts to avoid hazards rather than attempting to inspect finished products for the effects of
those hazards. The HACCP system can be used at all stages of a food chain, from food
production and preparation processes including packaging, distribution, etc. The Food and Drug
Administration (FDA) and the United States Department of Agriculture (USDA) require
mandatory HACCP programs for juice and meat as an effective approach to food safety and
protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and
juice are regulated by the FDA. All other food companies in the United States that are required to
register with the FDA under the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, as well as firms outside the US that export food to the US, are
transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
[citation needed]
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HACCP is believed to stem from a production process monitoring used during World
because traditional "end of the pipe" testing on artillery shells' firing mechanisms could not be
performed, and a large percentage of the artillery shells made[where?] at the time were either duds
or misfiring.[1] HACCP itself was conceived in the 1960s when the US National Aeronautics and
Space Administration (NASA) asked Pillsbury to design and manufacture the first foods for
space flights. Since then, HACCP has been recognized internationally as a logical tool for
adapting traditional inspection methods to a modern, science-based, food safety system. Based
on risk-assessment, HACCP plans allow both industry and government to allocate their resources
efficiently by establishing and auditing safe food production practices. In 1994, the organization
International HACCP Alliance was established, initially to assist the US meat and poultry
industries with implementing HACCP. As of 2007, its membership spread over other
professional and industrial areas.[2]
HACCP has been increasingly applied to industries other than food, such as cosmetics and
pharmaceuticals. This method, which in effect seeks to plan out unsafe practices based on
science, differs from traditional "produce and sort" quality control methods that do nothing to
prevent hazards from occurring and must identify them at the end of the process. HACCP is
focused only on the health safety issues of a product and not the quality of the product, yet
HACCP principles are the basis of most food quality and safety assurance systems. In the United
States, HACCP compliance is regulated by 21 CFR part 120 and 123. Similarly, FAO and WHO
published a guideline for all governments to handle the issue in small and less developed food
businesses.[3]
Hazard Analysis of Critical Control Points Principles
Introduction
Hazard Analysis Critical Control Points (HACCP) is a system which provides the framework for
monitoring the total food system, from harvesting to consumption, to reduce the risk of
foodborne illness. The system is designed to identify and control potential problems before they
occur. In its Model Food Code, the Food and Drug Administration has recommended the
HACCP system “because it is a system of preventive controls that is the most effective and
efficient way to assure that food products are safe ” (1999 FDA Model Food Code) . The
application of HACCP is based on technical and scientific principles that assure safe food.
Currently, the food industry, including foodservice, supports the use of HACCP and its
principles as the best system currently available to reduce and prevent foodborne illness. HACCP
was first developed and used by the Pillsbury Company in the late 1950’s to provide safe food
for America’s space program.
Federal and state regulatory agencies have adopted the HACCP approach. Beginning in January
of 1998, all seafood processors who ship their product across state lines will be required to have
HACCP plans in place. Also in 1998, USDA began to require that meat and poultry processing
plants have HACCP plans in place. Many state and local food regulatory agencies base their
inspections on HACCP principles and may, in certain instances, require HACCP plans for
specific food items. Food safety educators now use the principles of HACCP as the basis for
their educational programs.
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HACCP consists of seven steps used to monitor food as it flows through the establishment,
whether it be a food processing plant or foodservice operation. The seven steps of the HACCP
system address the analysis and control of biological, chemical and physical hazards.
In August of 1997, the National Advisory Committee on Microbiological Criteria for Foods
adopted new recommendations on “Hazard Analysis and Critical Control Point Principles and
Application Guidelines.” These guidelines are designed to facilitate the development and
implementation of effective HACCP plans. The new recommendations are reflected in this
document. For more information on HACCP principles, in particular formal HACCP, contact
your local extension educator. Also, the reference list includes several excellent resources on
HACCP.
HACCP Terminology
Critical Control Point (CCP) – A procedure/practice (control) in food handling/preparation that

will reduce, eliminate or prevent hazards. It is a “kill” step that kills microorganisms or a control
step that prevents or slows their growth.
Hazard – Unacceptable contamination, microbial growth, persistence of toxins or survival of

microorganisms that are of a concern to food safety.
Monitoring – Checking to determine if the criteria established by the critical control point(s)
(CCP) have been achieved.
Risk – Probability that a condition(s) will lead to a hazard.
Severity – Seriousness of the consequences of the results of a hazard.
Practical HACCP Principles
Practical HACCP principles adapt the seven HACCP steps into a form that is easily applied in a
non commercial setting. The seven steps deal with the issues of thorough cooking and cooling
which are the major causes of foodborne illness.
In order for this simplified, focused application of HACCP principles to be effective in reducing
the risk of foodborne illness, Standard Operating Procedures (SOP’s) of personal hygiene, basic
sanitation and food storage must be developed and adhered to. The SOP’s should be developed,
taking into consideration the types of foods that will be prepared during the foods labs, the
number of students involved in the food preparation activity and the type of equipment to be
used. The SOP’s can be listed in the form of a checklist, which can be checked off as each item
is accomplished.
Formal HACCP Seven Steps
1. Conduct a hazardous analysis.

The purpose of a hazardous analysis is to develop a list of hazards which are likely to cause
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injury or illness if they are not controlled. Points to be considered in this analysis B0
can include:
skill level of employees; transport of food; serving elderly, sick, very young children, immune-
compromised; volume cooling; thawing of potentially hazardous foods; high degree of food
handling and contact; adequacy of preparation and holding equipment available; storage, and
method of preparation. The next step is to determine if the factors may influence the likely
occurrence and severity of the hazard being controlled. Finally, the hazards associated with each
step in the flow of food should be listed along with the measures necessary to control the hazard.
2. Determine Critical Control Points (CCP’s)

A critical control point is any step in which hazards can be prevented, eliminated or reduced to
acceptable levels. CCP’s are usually practices/procedures which, when not done correctly, are
the leading causes of foodborne illness outbreaks. Examples of critical control points include:
cooking, cooling, re-heating, holding. To determine CCP’s ask the following questions:
 At this step in preparation can food become contaminated and/or can contamination
increase?
 Can this hazard be prevented through corrective action(s)?
 Can this hazard be prevented, eliminated or reduced by steps taken later in the
preparation process?
 Can you monitor the CCP?
 How will you measure the CCP?
 Can you document the CCP
3. Establish Critical Limits

A critical limit ensures that a biological, chemical or physical hazard is controlled by a CCP.
Each CCP should have at least one critical limit. Critical limits must be something that can be
monitored by measurement or observation. They must be scientifically and/or regulatory based.
Examples include: temperature, time, pH, water activity or available chlorine.
4. Establish Monitoring Procedures

Monitoring is a plan which includes observations or measurements to assess whether the CCP is
being met. It provides a record of the “flow of food” through the establishment. If monitoring
indicates that the critical limits are not being met, then an action must be taken to bring the
process back into control. The monitoring system should be easy to use and meet the needs of the
food establishment, as well as the regulatory authority. It is important that the job of monitoring
be assigned to a specific individual and they be trained on the monitoring technique.
5. Establish Corrective Actions

If the criteria for a CCP is not being met, some type of corrective action must be taken. They
must meet the standards established in Step 3, must be based on facts for normal working
conditions and be measurable. Corrective actions may range, for example, from “continue
cooking until the established temperature is reached” to “throw out the product,” depending on
the severity of the situation.
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HACCP plans should include the following: who is responsible for implementingB0
the corrective
action and what corrective action was taken. They should be established in advance as part of the
HACCP plan.
6. Establish verification procedures

These procedures are activities, other than monitoring, that determine the validity of the HACCP
plan and that the system is operating according to the plan. An important aspect of verification is
to determine if the plan is scientifically and technically sound. Also, that all the hazards have
been identified and that, if the HACCP plan is properly implemented, these hazards can be
effectively controlled. Verification can be accomplished by expert advice and scientific studies
and observations of the flow of food, measurements and evaluations. Another means of
verification is an on site review of the established critical limits. Each CCP will have one
independent authority. This verification step provides an opportunity to make modifications to
the plan if necessary.
7. Establish record-keeping and documentation procedures

Record-keeping and documentation procedures should be simple to complete and include
information that illustrates that the established standards are being met. Employees need to be
trained on the record-keeping procedures and why it is a critical part of their job. Examples of
records include time/temperature logs, checklists, forms, flowcharts, employee training records,
and SOP’s.
(“Hazard Analysis Critical Control Point Principles and Application Guidelines”, Adopted
August 14, 1997, National Advisory Committee on Microbiological Criteria for Foods)
Practical HACCP Seven Steps
1. Review menu and highlight potentially hazardous foods
2. Review recipes that include potentially hazardous foods and highlight problem
ingredients.
3. Include critical temperatures and times in the recipes/procedures.

Use critical temperatures established by USDA for consumer use. (Note critical temperatures
may be somewhat different for the food industry and are based on state/federal regulations.)
4. Check food temperatures during preparation, holding, cooking and cooling.

Food temperatures should be checked using a bi-metallic food thermometer. Remember, when
cooling food, time is critical. The food needs to be cooled to 40° F in no more than two hours.
5. Correct if required temperatures are not being met.

Specific steps to be taken should be previously established and could be included in SOP’s. For
example, when roasting a chicken, if at the end of the prescribed cooking time, if the temperature
has not reached 180°F, the correction is to continue cooking until that temperature is reached.
However, in some cases, the “correction” may involve throwing the food item away because
throughout the preparation process, the food may have been mishandled.
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B0
6. Verify that the previous steps are being followed.
 Review plan
 Review deviations and corrections
 Visual inspection
7. Record time and temperatures.

A system for recording temperatures should be developed. This system can be in the form of a
notebook or charts that includes the intervals at which the temperatures should be taken and
recorded.

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Institution Name ባህርዳርፖሊቴክኒክኮሌጅ BTC/262-04

SECTOR: ECONOMMIC INFRASTRUCTURE

MODULE TITLE: Establishing Quality Systems and Procedures

MODULE CODE: CON RSC4 M04 0911

MODULE TITLE: Establishing Quality Systems and Procedures

MODULE CODE: CON RSC4 M04 0911

NOMINAL DURATION: 80 hrs

LO 1 establish quality specifications for work output

LO 2 identify hazards and critical control points

LO 3 assist in planning of quality assurance procedures

LO 4 implement quality assurance procedures

LO 5 monitor quality of work outcome

LO 6 participate in maintaining and improving quality at work

LO 7 report problems that affect quality

Contractor Quality Management Process

A more structured approach is to draft a quality management program, devise a quality

Quality Assurance and Quality Control

Elements of a Quality Management Process

Contractor Quality Management Program

Project Quality Management

 Functionality is the degree, by which equipment performs its

Quality characteristics must be included in all material, equipment and

The proper level of maturity to which an organization should strive is

 Level 1. Informal level, there is no defined processes for quality

Quality Management Process Outline:

Here are 6 steps to develop a quality control process:

1. Set your quality standards.

 Answering all customer calls by the second ring

2. Decide which quality standards to focus on.

3. Create operational processes to deliver quality.

4. Review your results.

PROJECT QUALITY MANAGEMENT

Quality assurance & Quality control

Quality System, Quality Assurance, and Quality Control Relationships

Differences between QA and QC

See training courses for these crucial functions:

Quality assurance can be defined as "part of quality

Quality control can be defined as "part of quality management focused on fulfilling quality

QA, QC, and Inspection

Quality Assurance and Audit Functions

Quality Assurance and Auditing

What are the four main elements of quality?

What are the 7 key principles of quality?

What are the elements of quality?

 Quality Objectives. ...

What are the key elements of TQM?

Organizations must adopt an interdisciplinary series of quality controls to achieve these

Quality objectives for this organization could include:

What are the skills required for quality control?

What are three responsibilities of a quality control specialist?

What skills do you need to be a quality assurance?

What are the pillars of TQM?

What are the 5 elements of QAPI?

What come first QA or QC?

Quality assurance comprises administrative and procedural activities implemented in a quality

10 ways to maintain consistent project quality

10 ways to maintain consistent project quality

3. Stick to the project requirements!

5. Perform quality assurance

6. Control the quality

Requirements management and quality management go hand in hand. Clear, well-defined

8. Follow the project processes